Study of Ketorolac Versus Opioid for Pain After Endoscopy

Phase 4

Completed

• Conditions: Kidney Calculi; Ureteral Calculi
• Interventions: Drug: Oxycodone; Drug: Ketorolac

• Registration Number: NCT03888144
• Lead Sponsor: The Cleveland Clinic

Brief Summary

A double blind randomized controlled trial designed to compare pain control and safety with ketorolac and oxycodone in the post-operative setting for patients undergoing ureteroscopy for treatment of urinary stones. Patients are followed for five days after their surgery as they record their pain scores, medication utilization, and stent related symptoms.

Detailed Description

Pain is the leading cause for unplanned emergency department visits and readmissions after ureteroscopy (URS), making post-operative analgesic stewardship a priority given the current opioid epidemic. The investigators conducted a double-blinded, randomized controlled trial (RCT), with non-inferiority design, comparing nonsteroidal anti-inflammatory drugs (NSAIDs) to opiates for postoperative pain control in patients undergoing URS for urolithiasis.

Patients were randomized and blinded to either oxycodone (5mg) or ketorolac (10mg), taken as needed, with 3 non-blinded oxycodone rescue pills for breakthrough pain. Primary study outcome was visual analog scale pain score on post-operative days 1-5. Secondary outcomes included medication utilization, side effects, and Ureteral Stent Symptoms Questionnaire (USSQ) scores.

Study Timeline

• Study Start: 2017-10-13
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Status Verified: 2021-08
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Patients with kidney or ureteral stones confirmed on imaging (CT of the abdomen pelvis) and who elect for definitive treatment via unilateral ureteroscopy at one of two hospital sites within a tertiary care institution
• Patients who post-operatively receive a unilateral ureteral stent
• Capable of giving informed consent
• Capable and willing to fulfill requirements of the study

Exclusion Criteria

• Active or history of peptic ulcer disease, gastrointestinal bleeding or perforation
• History of coronary artery bypass graft surgery
• History of a bleeding disorder
• GFR less than 60 mL/min/1.73m2 (MDRD equation)
• Chronic use of opioid or other pain medication including NSAIDs (greater than 12 weeks)
• Known allergy to either ketorolac or oxycodone
• Known or suspected pregnancy
• Solitary kidney
• Patients taking anticoagulant medication or antiplatelet medication (e.g. warfarin, clopidogrel, pradaxa, rivaroxaban, apixaban etc).
• Inability to give informed consent or unable to meet requirements of the study for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone group	Oxycodone	Patients randomized to 20 pills of 5 mg oxycodone by mouth every 6 hours as needed for pain after ureteroscopy.
Ketorolac group	Ketorolac	Patients randomized to 20 pills of 10 mg ketorolac by mouth every 6 hours as needed for pain after ureteroscopy.

Primary Outcome Measures

Name	Time	Method
Visual Analog Pain Score	Daily for 5 days	Averaged pain score over five days post-operatively (measured 0 to 10 mm)

Secondary Outcome Measures

Name	Time	Method
Medication Adverse Effects	Daily for 5 days	Patient-reported medication related side effects
Ureteric Stent Symptom Questionnaire	Post-operative days 1 and 5	A validated assessment tool for stent-related symptoms and their impact on patient quality of life

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States